Sleep Disorder
Conditions
Keywords
sleep onset latency, bedtime resistance
Brief summary
The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the effectiveness of the Strongest Families distance intervention compared to usual or standard care that is typically provided to children with mild to moderate sleep onset latency and/or bedtime resistance difficulties. This is a single-centre trial based at the IWK Health Centre. The primary outcome is change in sleep patterns (sleep onset latency and/or bedtime resistance).
Detailed description
The purpose of the Family Help Sleep Program is to deliver, primary care mental health services to children and their families in the comfort and privacy of their own home. Approximately 80 children (6-12 years of age)suffering from mild to moderate sleep onset latency and/or bedtime resistance will be randomized. The intervention is delivered from a distance, using an educational handbook and telephone consultation with a trained paraprofessional coach who is supervised by a licensed health care professional. The telephone coach delivers consistent care based on written protocols, with on-going evaluation by a professional team.
Interventions
BEHAVIORALFHP Sleep Program
Cognitive-Behavioral Intervention
Sponsors
IWK Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* children 5-12 years of age * attending grades primary-6 (Elementary School) * sleep onset latency and/or bedtime resistance * speak and write English * provides parental authorization * has access to telephone in home
Exclusion criteria
* any mental health disease with the exclusion of disruptive behavior disorder * neurological conditions * moderate to severe cognitive impairment * has received a behavioral intervention for sleep difficulties in the past 6 months * nocturnal enuresis * sleep apnea * co-sleeping
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Child Sleep Habits Questionnaire | baseline, 2months (end of treatment) & 6 month follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Actigraph recordings | daily during treatment; baseline, 2 & 6 months follow-up |
| Child Behaviour Checklist (CBCL) | baseline, 2months (end of treatment) & 6 month follow-up |
| Sleep diary | daily during treatment; on follow-up at 2 & 6 MONTHS post randomization |
| Parenting Stress Index | baseline, 2months (end of treatment) & 6 month follow-up |
| Child Health Questionnaire | baseline, 2months (end of treatment) & 6 month follow-up |
| Satisfaction scale (researcher developed) | end of treatment |
Countries
Canada
Outcome results
None listed